N/A
N=318
Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening
Amblyopia · Strabismus
Bottom Line
View on ClinicalTrials.gov: NCT02536963 ↗Enrolled (actual)
318
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device — 6; 249; 0; 45 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pediatric Vision Scanning device (Device); Reference examination (Other)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Rebiscan, Inc.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Amblyopia and Strabismus in Children Ages 2-5 Using Automated Pediatric Vision Scanner Device |
6; 249; 0; 45 | — |
Summary
Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children. They are irreversible if not detected and corrected by the age of seven, however half of all cases are missed because the conditions do not always manifest themselves and pediatricians are unable to reliably detect the conditions. The current health care system badly needs an accurate and effective approach toward detecting amblyopia and strabismus in preschool children.
The study will be conducted in busy, ethnically and racially diverse primary care sites operated by the Kaiser Permanente system and compare the outcomes of testing with a Pediatric Vision Scanner with outcomes the current standard of care.
Eligibility Criteria
Inclusion Criteria
- Between the ages of 8-10, presenting for a well-visit (for enrollment for first primary outcome)
- Between the ages of 2-5, presenting for a well-visit (for enrollment for second primary outcome)
Exclusion Criteria
- No developmental delay or cognitive deficit
- No visually obvious ocular conditions that would warrant specialist referral
Data sourced from ClinicalTrials.gov (NCT02536963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.